MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F; FEEDING DEVICE

Model Number	000720
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that approximately 15 days post feeding tube placement, the catheter allegedly dislodged.It was further reported that the catheter fell out of the patient.There was no reported patient injury.
Event or Problem Description
It was reported that approximately fifteen days post feeding tube placement, the catheter allegedly was dislodged.It was further reported that the catheter fell out of the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one tri-funnel replacement gastrostomy tube 20f was returned for evaluation.Gross, microscopic evaluation and functional testing were performed.The investigation is confirmed for tube dislodged, migration and balloon rupture issue as a rupture to the balloon was noted from the distal end of the device.The balloon was inflated with approximately 10ml of water and immediately deflated.A leak was observed from the rupture on the balloon.A definitive root cause could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2022), g3.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, 20F
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10784384
• Report Number: 3006260740-2020-20363
• Device Sequence Number: 11712078
• Product Code: KNT
• UDI-Device Identifier: 00801741037153
• UDI-Public: (01)00801741037153
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 000720
• Device Catalogue Number: 000720
• Device Lot Number: NGDW3857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other